3M Trimatic M Modular System and Accessories
FDA 510(k) K880565 · 3M Company
510(k) numberK880565
Submission
- Device name
- 3M Trimatic M Modular System and Accessories
- Applicant
- 3M Company
Cottae Grove, MN, US - Received
- February 10, 1988
- Decision date
- March 21, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IXW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K111167 | Xtender Film Processor, Sprint Film Processor Model Xtender Model SprintIXW · Traditional | Velopex International, Inc. | 08/18/2011SE |
| K093503 | Intrax Film ProcessorIXW · Traditional | Velopex International, Inc. | 01/06/2010SE |
| K091628 | Optimax, Compact 2, Optimax 2010, EcomaxIXW · Traditional | Protec GmbH & Co. KG | 08/21/2009SE |
| K024342 | Radiographic Film Processor, Models XP400 and XP1000IXW · Traditional | Daito Co., Ltd. | 04/23/2003SE |
| K023825 | Film Processor, Model Life Ray Pro 2500IXW · Abbreviated | S.A.I.E.P. S.R.L. | 02/12/2003SE |
| K023801 | Film Processor, Model Life Ray Pro 1000IXW · Abbreviated | S.A.I.E.P. S.R.L. | 02/12/2003SE |
| K023613 | AX200 Automatic X-Ray Film Processor, Model 6586.036IXW · Traditional | Alphatek Corp. | 01/23/2003SE |
| K022154 | Level 356 X-Ray Film Processor, Models MD & Md-DIXW · Traditional | Fischer Industries, Inc. | 09/30/2002SE |
| K002640 | Freedom Automatic Film ProcessorIXW · Abbreviated | J. Morita USA, Inc. | 11/08/2000SE |
| K002404 | Micro-Max, Model 319IXW · Traditional | Tek Marketing, Inc. | 08/30/2000SE |
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| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 10/18/2024SE |
| K241710 | 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490…FRC · Traditional | 09/12/2024SE |
| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC · Special | 06/27/2024SE |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen…FRC · Special | 06/27/2024SE |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M…FRC · Traditional | 03/15/2024SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 05/18/2023SE |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional | 09/23/2022SE |
Questions and answers
When was 3M Trimatic M Modular System and Accessories cleared by the FDA?
3M Trimatic M Modular System and Accessories (K880565) received a 510(k) decision of Substantially Equivalent on March 21, 1988, 40 days after the submission was received.
What is the product code of K880565?
The FDA product code is IXW – Processor, Radiographic-Film, Automatic, a Class II (moderate risk) device regulated under 21 CFR 892.1900.